Kornimate/medical-research-clean huggingface dataset:
clinical study-evaluate performance&safety "aer-o-scope" in colon of low risk patients

Conditions: Colon Cancer; Rectal Cancer

Summary: a double center study to evaluate the safety and efficacy of the aer-o-scope in traveling through the colon in low risk subjects.

asymptomatic adults between the ages of 18 and 70 will undergo screening of the colon using the aer-o-scope, under fluoroscopy, following by screening of the colon using a standard approved colonoscopy for determination of safety.

Eligibility criteria:
inclusion criteria: * male or female patients between 18 and 70 years of age * patients who are generally healthy and classified as low risk for crc * patients who are ready to undergo standard colonoscopy examination including colon prep. * signed informed consent exclusion criteria: * patients with any known gi related symptoms complaints or gi diseases * patients with cancer or other life threatening diseases or conditions * patients with unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal' gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety. patients with a known history of blood clotting problems and /or who are on anti-coagulant therapy and cannot stop treatment for the purpose of this study. (patients taking up to 100mg aspirin for prophylactic treatment are acceptable for this study). * pregnant women * patients who underwent abdominal surgery that is deemed by the investigator to effect the procedure * morbid obesity (bmi \> 40) * drug abuse or alcoholism * bed-ridden patient * inadequate communication with the patient * patients under custodial care * participation in current clinical study or clinical study within 30 days prior to the procedure

Keywords: polyp
a clinical study testing the safety and efficacy of crizotinib in east asian patients with anaplastic lymphoma kinase (alk) positive advanced non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this is an open-label multi-center phase 2 efficacy and safety study of crizotinib in east asian patients with advanced non-squamous nsclc harboring a translocation or inversion event involving the alk gene locus who have received only one prior chemotherapy regimen for advanced nsclc and this regimen must have been platinum-based. primary objective of this study is to assess the anti-tumor activity and safety profile of crizotinib. secondary objectives are to evaluate clinical efficacy including median progression-free survival (pfs) and 1-year pfs rate, overall survival (os), disease control rate (dcr) at 6 and 12 weeks, time to response (ttr), and duration of response (dr).


Eligibility criteria:
inclusion criteria: * proven diagnosis of locally advanced or metastatic non-squamous cell carcinoma of the lung * positive for translocation or inversion events involving the alk gene locus * patients must have had progressive disease after only one prior chemotherapy regimen. this regimen must have been platinum-based and may have included maintenance therapy. * evidence of personally signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. exclusion criteria: * current treatment on another therapeutic clinical trial. * prior therapy directly targeting alk. * any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack. * ongoing cardiac dysrhythmias of nci ctcae grade \>=2, uncontrolled atrial fibrillation of any grade, or qtc interval \>470 msec. * pregnancy or breastfeeding. * use of drugs or foods that are known potent cyp3a inducers/inhibitors/substrates with narrow therapeutic indices. * known hiv infection * known interstitial lung disease or interstitial fibrosis * other severe acute or chronic medical conditions (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study.

Keywords: crizotinib alk nsclc non-small cell lung cancer asian
a genome-wide association study for neonatal diseases

Conditions: Neonatal Disease; Necrotizing Enterocolitis

Summary: this is an observational study to identify genetic risks for neonatal diseases, necrotizing enterocolitis (nec) using genome-wide association study (gwas) and enterotype investigation. we hypothesize that specific genetic factors and microbiome could predispose preterm neonates for the development of nec.

nec is the most frequently encountered surgical emergencies and a life-threatening disease that predominantly affects preterm neonates. the incidence is estimated to be 7-10% in ver low birth weight (vlbw) neonates (lin and stoll, 2006; neu and walker, 2011). however, a significant proportion of affected neonates (20-30%) develops severe progressive disease with intestinal necrosis and complications resulting in gut perforation and peritonitis which require urgent surgical intervention (surgical cases) (sharma et al., 2006). the mortality rate of surgical cases is high (25-50%), and may increase to 100% in patients with pan-necrosis of the bowel. those neonates who survived often suffer severe morbidity, including short bowel syndrome, parenteral nutrition-associated cholestasis, poor physical growth and neurodevelopmental impairment (neu and walker, 2011; salhab et al., 2004). however, the etiology and pathophysiology of nec remain incompletely understood. the current knowledge has directed towards multiple predisposing factors which include prematurity, immature gut mucosa and host defense immunity, formula milk feeding and altered microbial colonization in the gut resulting in excessive inflammatory response, leading to irreversible intestinal cell death and gut necrosis (neu and walker, 2011; chan et al., 2013). to date, no genetic risk markers or biomarkers are available for reliable prediction of neonates who are at high risk of developing nec. besides host genetic factors, gut bacteria have been reported to predispose neonates to disease risk (mai et. al., 2011; neu and pammi, 2018). in this study, we shall conduct a gwas on chinese preterm neonates for identification of genetic risks for nec and determine gut microbiome structure (enterotype) of nec.

Eligibility criteria:
inclusion criteria: chinese infants admitted in the neonatal unit (nnu) exclusion criteria: refuse consent for study
o-sema-fast: a research study to understand how oral semaglutide works in people with type 2 diabetes who plan to fast during ramadan in the united arab emirates, saudi arabia, and kuwait

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to look at the change in blood sugar levels in people with type 2 diabetes who are using oral semaglutide and planning to fast during ramadan. participants will take oral semaglutide as prescribed by the study doctor. the study will last for about 5 months (20 weeks). participants will be asked to complete a patient diary about how and when they take the oral semaglutide tablets. participants will complete this diary during the study period as instructed by study doctor.


Eligibility criteria:
inclusion criteria: 1. signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) 2. the decision to initiate treatment with commercially available oral semaglutide has been made by the patient/legally acceptable representative (lar) and the treating physician before and independently from the decision to include the patient in this study 3. male or female, age above or equal to 18 years at the time of signing informed consent 4. patients diagnosed with t2d who intend to fast during ramadan 5. patient should be on oral semaglutide (at least 4 weeks on maintenance dose) with or without other oads 6. available hba1c value ≤ 30 days prior to the patient enrolment visit (v1) or hba1c measurement taken in relation with the patient enrolment visit (v1) if in line with local clinical practice exclusion criteria: 1. previous participation in this study. participation is defined as having given informed consent in this study 2. participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days prior to the patient enrolment visit (v1) and throughout the duration of the study 3. patients with type-1 diabetes and gestational diabetes 4. patients who are pregnant or are planning to become pregnant during the conduct of the study 5. patients who are breastfeeding 6. patients on insulin therapy within 2 weeks prior to enrolment 7. mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
effect of the membrane blue dual® dye on the retinal sensitivity in macular hole surgery

Conditions: Macular Hole Surgery

Summary: the idiopathic macular hole, age-related disease, is a major cause of vision loss and affects at least two persons in 1000 after 40 years. this hole causes an acute decline linked to a central scotoma. the only treatment is surgical. the surgery involves removing the posterior hyaloid (vitreous base) to relieve the tensile forces. to be sure the removed is complete and to facilitate the closure of the hole, a peeling of the internal limiting, the outermost layer of the retina, is often suggested. the inner limiting membrane (ilm), transparent and adherent to the retina, is colored with vital dyes to facilitate its removal. after closure of the macular hole, the central scotoma disappears but a diffuse and asymptomatic loss of pericentral sensitivity is often described. this sensitivity decrease could be induced by the dyes used during surgery. this effect has not been studied clinically for recent dyes (membrane blue dual®, brilliant blue®, acid violet®) at the concentrations used, but is known in electrophysiology at higher concentrations, at least on the isolated retina models. it would be interesting to search for a decrease in retinal peri-foveal postoperative sensitivity after surgery of macular holes, performed with the usual dyes. only microperimetry can observe this decrease in retinal sensitivity. this is a noninvasive technique that explores the macular visual field. it is performed without iris dilatation and allows an automatic exploration ensuring rapid and accurate analysis of retinal sensitivity.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * lower idiopathic macular hole inferior or equal to 600 micron millimeter * undergoing macular hole surgery exclusion criteria: * myopia \> -3 diopters * pregnant women * no health insurance coverage * refusal to participate in the study

Keywords: inner limiting membrane microperimetry surgical's dye
study of hepatic arterial infusion to treat biliary tract carcinomas

Conditions: Biliary Tract Cancer

Summary: this phase ii clinical trial is to study the effectiveness and safety of continuous hepatic arterial infusion (hai) of oxaliplatin and fluorouracil in patients with unresectable biliary tract carcinomas, and to explore a better first-line treatment regimen for these patients.


Eligibility criteria:
inclusion criteria: * patient must have histologically or cytologically confirmed biliary tract carcinomas including intrahepatic, hilar cholangiocarcinoma and gallbladder cancer without evident liver metastasis. * patient must have locally advanced disease that is unresectable after review by the hepatobiliary surgery service * patient's eastern cooperative oncology group (ecog) performance status must be =\ = 60%) * absolute neutrophil count \>= 1,500/mcl * platelets \>= 100,000/mcl * hemoglobin \>= 90g/l * total bilirubin =\< 2 x institutional upper limit of normal * aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase \[sgot\])/alanine aminotransferase (alt) (serum glutamic pyruvate transaminase \[sgpt\]) =\< 2.5 x institutional upper limit of normality * creatinine =\< 1.5 x institutional upper limit of normal * albumin \>= 30g/l * patient must be able to understand and willing to sign a written informed consent document exclusion criteria: * patients who have had prior chemotherapy and other antitumor therapy treatment * patient who is receiving any other investigational agents * patient who have evident distant (m) disease; * patient who have a diagnosis of hepatic encephalopathy * patients who have a diagnosis of sclerosing cholangitis. * patients who have a diagnosis of gilbert's disease. * patients who have clinical ascites * patient must not have any uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus and hypertension, or psychiatric illness/social situations that would limit compliance with study requirements * no other malignancy except localized basal cell or squamous cell skin cancer in the past 5 years * patient who is pregnant or lactating * patient allergic to iodine contrast medium * uncontrolled severe coagulation disorders (inr \< 1.5 in patients not on warfarin therapy)

Keywords: cholangiocarcinoma gallbladder cancer infusions intra-arterial
normal saline flushes at 12 vs 24 hours intervals for maintaining peripheral intravenous catheters patency

Conditions: Pain

Summary: children admitted in a ward often require a peripheral intravenous catheter to provide access for administration of medications, nutrients, fluids, blood products. vascular access in children is a frequent and stressful procedure that should be performed as infrequently as possible in order to reduce the child's pain experience and the child's and family's level of distress. the maintenance of patency of indwelling catheters is therefore relevant to minimize need for replacement and children discomfort. recent studies investigated the most effective and safe method of maintaining peripheral intravenous lock (peripheral ivl) in children. most of these studies focused primary on the use of heparin versus saline flushes, showing similar efficacy of the two approaches. to the best of the investigators knowledge no study addressed the issue of the optimal flushing frequency of normal saline . the aim of this study was to evaluate the efficacy of normal saline flushes, at 12 and 24 hours intervals.


Eligibility criteria:
inclusion criteria: * age between 1 and 17 years * peripheral intravenous catheter 22 g or 24 g * need to maintain the access for at least 24 hours without infusion exclusion criteria: * need for continuous infusion therapy * programmed therapy

Keywords: peripheral intravenous catheter peripheral intravenous lock normal saline patency management of peripheral intravenous catheter
exploratory study to evaluate uncorrected distance vision and quality of vision after light treatments of an implanted rxsight light adjustable lens (rxlal) with the light delivery device (ldd) in subjects with preoperative corneal astigmatism

Conditions: Aphakia; Cataract

Summary: the objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the mcalinden qov questionnaire 3 months following the final lock-in treatment of the implanted rxsight light adjustable lens (rxlal) with the light delivery device (ldd) in subjects with preoperative keratometric astigmatism. this is an exploratory study. no primary effectiveness endpoints will be defined.


Eligibility criteria:
inclusion criteria: * must sign a written informed consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the rxlal. * between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. * study eye must have preoperative keratometric cylinder of ≥0.50 d and ≤3.00 d. * study eye must have cataract causing reduction in best corrected distance visual acuity (bcdva) to a level of 20/32 or worse with or without a glare source. * willing and able to comply with the requirements for study specific procedures and visits. exclusion criteria: * study eye with zonular laxity or dehiscence. * study eye with pseudoexfoliation. * study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen. * study eye with diabetes with any evidence of retinopathy. * study eye with evidence of glaucomatous optic neuropathy. * study eye with history of uveitis. * study eye with prior history of intacs, radial keratotomy (rk), conductive keratoplasty (ck), astigmatic keratotomy (ak), phakic implantable collamer lens (icl), corneal inlay, or with previous pterygium excision unless the pterygium did not extend more than 2mm onto the cornea from the limbus. * subjects taking systemic medication that may increase sensitivity to uv light. * subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen. * study eye with history of ocular herpes simplex virus. * study eye with history of a congenital color vision defect

Keywords: light adjustable lens intraocular lens lal
pragmatic implementation of mindful awareness in body oriented therapy

Conditions: Non-pharmacologic Management of Chronic Pain

Summary: this is a one group study using a hybrid implementation design.

the proposed pilot study will collect preliminary data to support a larger hybrid effectiveness-implementation study designed to examine the implementation of the evidence-based mindful awareness in body-oriented therapy (mabt), delivered by massage therapists, on patient and implementation science outcomes in an interdisciplinary chronic pain clinic. the combined foci of this mixed-methods pilot study is expected to provide an indication of implementation success, highlight implementation processes, and show treatment effectiveness on health outcomes.1 mabt is a mind-body therapy designed to teach interoceptive awareness skills for symptom management and emotion regulation. the proposed pilot study uses mixed methods and a single-group repeated measures design to explore mabt implementation and to estimate the effect of mabt to reduce symptomatic distress in the treatment of chronic pain at the osher center for integrative medicine at vanderbilt clinic (ocim).

Eligibility criteria:
inclusion criteria: * patient attending clinic and who received a referral to mabt exclusion criteria: * under 18
investigation of genetic disease marker associated with korean glaucoma patients

Conditions: Single-nucleotide Polymorphism (SNP) for Glaucoma

Summary: a single-nucleotide polymorphism (snp) analysis of dna obtained from peripheral blood of the glaucoma patients and the normal control will be performed to find genetic marker for primary open angle glaucoma.

unrelated korean subjects who have primary open angle glaucoma were recruited in the current study. genotyping for various snp associated with poag due to the linkage disequilibrium patterns is to be performed. genotypes would be statistically compared between patients with primary open angle glaucoma and normal control subjects free of any eye diseases.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary open angle glaucoma exclusion criteria: * primary open angle glaucoma combined with congenital ocular disease * primary open angel glaucoma combined with other ocular disease * significant systemic disease other than systemic hypertension and diabetes

Keywords: snp single-nucleotide polymorphism glaucoma primary open angle glaucoma
spread and course of covid-19 infections

Conditions: Covid-19; Virus Disease

Summary: the overall goal is to study the immune response to sars-cov-2 infection over the period of one year in the blood of a representative cohort of eth students/employees.


Eligibility criteria:
inclusion criteria: * eth employee or eth student and their family members living in the same household at the start of the study * between 18 and 64 years of age at the start of the study * signed informed consent exclusion criteria: * age over 64 years at the start of the study * in quarantine or self-confinement at the start of the study * active covid-19 infection at the start of the study: * diagnosed with a laboratory test * suspected based on typical symptoms such as fever (\>38°c), acute pulmonary ex-acerbation or sudden loss of gustatory taste * the following medical condition * with continuous steroid therapy/ chemotherapy/immunsuppressive therapy * in treatment for cancer * with severe autoimmune disease
a study of ociperlimab with tislelizumab compared to pembrolizumab in participants with untreated lung cancer

Conditions: Non-small Cell Lung Cancer; NSCLC

Summary: the purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with pd-l1 high, locally advanced/recurrent or untreated metastatic nsclc.


Eligibility criteria:
key inclusion criteria: 1. histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (nsclc) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous nsclc. 2. no prior systemic treatment for metastatic nsclc. 3. agreement to provide archival tissue or fresh biopsy (if archival tissue is not available). 4. tumors with pd-l1 expressed in ≥ 50% tumor cells. 5. at least 1 measurable lesion as defined per recist v1.1. 6. ecog performance status ≤ 1. key exclusion criteria: 1. known mutations in the epidermal growth factor receptor (egfr) gene, anaplastic lymphoma kinase (alk) fusion oncogene, braf v600e, or ros1. 2. prior therapy with an anti-programmed cell death protein (anti-pd)-1, anti-pd-ligand (l)-1, anti-pd-ligand-2, anti-t-cell immunoglobulin and itim (anti-tigit) domain, or any other antibody or drug specifically targeting t-cell costimulation or checkpoint pathways. 3. active leptomeningeal disease or uncontrolled, untreated brain metastasis. 4. active autoimmune diseases or history of autoimmune diseases that may relapse. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: locally advanced unresectable metastatic tislelizumab bgb-a317 ociperlimab bgb-a1217 pembrolizumab anti-tigit